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Report for Clinical Trial NCT03428178

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Efficacy Study of Gene Therapy for The Treatment of Acute LHON Onset Within Three Months

Efficacy Study of Gene Therapy for The Treatment of Acute Leber's Hereditary Optic Neuropathy (LHON) onset within three months

NCT03428178 Acute LHON Onset Within Three Months Onset Between 3 to 6 Months Onset Between 6 to 12 Months Onset Between 12 to 24 Months Onset Between 24 to 60 Months Onset Over 60 Months
MeSH:Optic Atrophy, Hereditary, Leber
HPO:Leber optic atrophy

1 Interventions

Name: rAAV2-ND4

Description: rAAV2-ND4 of vitreous cavity injection
Type: Drug
Group Labels: 1

rAAV2-ND4


Primary Outcomes

Description: The Best Corrected Visual Acuity

Measure: BCVA

Time: Change from Baseline at 12 months

Secondary Outcomes

Description: Visual Field index

Measure: Computerized Visual Field

Time: Change from Baseline at 12 months

Description: Mean Defect

Measure: Computerized Visual Field

Time: Change from Baseline at 12 months

Description: visual evoked potential

Measure: VEP

Time: Change from Baseline at 12 months

Description: retinal nerve fiber layer

Measure: RNFL

Time: Change from Baseline at 12 months

Description: Before and after the treatment,Liver function in plasma will be checked.

Measure: Liver function in plasma

Time: Before treatment and in the first ,third,sixth,twelfth month after the treatment

Description: Before and after the treatment,kidney function in plasma will be checked.

Measure: kidney function in plasma

Time: Before treatment and in the first ,third,sixth,twelfth month after the treatment

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 G11778A

This is a multi - center , prospective study of 120 patients with the G11778A mutation in Mt-DNA.This clinical trial recruited 20 patients with the 11778 mutation of MT-DNA onset within three months,20 between 3 to 6 months,20 between 6 to 12 months,20 between 12 to 24 months,20 between 24 to 60 months,and 20 over 60 months.. --- G11778A ---



HPO Nodes


HPO: